Unique ID issued by UMIN | UMIN000010038 |
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Receipt number | R000011757 |
Scientific Title | Endeavor Zotarolimus Eluting Stent Post Marketing Surveillance in Japan |
Date of disclosure of the study information | 2013/02/14 |
Last modified on | 2013/02/14 14:22:51 |
Endeavor Zotarolimus Eluting Stent Post Marketing Surveillance in Japan
Endeavor PMS Japan
Endeavor Zotarolimus Eluting Stent Post Marketing Surveillance in Japan
Endeavor PMS Japan
Japan |
Ischemic Heart Disease
Cardiology |
Others
NO
Responding to the condition set with the marketing approval, according to the provisions of Article 14-4 (re-examination of new medical device) of the Pharmaceutical Affairs of Japan, to assess the efficacy and safty of Endeavor Zotarolimus Eluting Stent in actual clinical setting in Japan.
Safety,Efficacy
Confirmatory
Pragmatic
Not applicable
Survival free of Major Adverse Cardiac Events (MACE) at 12 months after index procedure
Cummulative incidence rate of late and very late stent thrombosis (VLST) at 5 years after index procedure
Observational
Not applicable |
Not applicable |
Male and Female
N/A
N/A
2000
1st name | |
Middle name | |
Last name | Kazunori Takamoto |
Medtronic Japan Co., Ltd
QA-PMS
2-14-1 Higashi Shimbashi, Minato-ku, Tokyo 105-0021 Japan
03-6430-7116
1st name | |
Middle name | |
Last name | Koichiro Oyama |
Medtronic Japan Co., Ltd
CV-PMS
2-14-1 Higashi Shimbashi, Minato-ku, Tokyo 105-0021 Japan
03-6430-7686
Koichiro.oyama@medtronic.com
Medtronic Japan Co., Ltd
None
Self funding
None
None
NO
2013 | Year | 02 | Month | 14 | Day |
Unpublished
No longer recruiting
2009 | Year | 04 | Month | 20 | Day |
2009 | Year | 07 | Month | 01 | Day |
Prostecitve consecutive registry
2013 | Year | 02 | Month | 14 | Day |
2013 | Year | 02 | Month | 14 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000011757
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